BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1021244 · Received March 28, 2008

    Report

    Report Number
    3004209178-2008-01672
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 29, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD AN INFECTION OF HER INTERSTIM DEVICE AND WAS PLACED ON ANTIBIOTICS. THE PT NOTICED A RED LINE ACROSS HER LEAD SITE AND HAD AN ABCESS, WHICH BURST. SHE ALSO EXPERIENCED PAIN AND FEVER. FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL 3093 LOT # V076384| IMPLANTED| EXPLANTED| EXPLANTED| IMPLANTED| EXTENSION MODEL 3095 LOT # NAH037523V